Sertaconazole nitrate is designated chemically as
(±)-1-[2,4-dichloro-β-[(7-chlorobenzo-[b]thien-3-yl)methoxy]phenethyl]imidazole
nitrate. It has a molecular weight of 500.8. The molecular formula is C20H15Cl3N2OS
• HNO3, and the structural formula is as follows:

For Consumers

What are the possible side effects of sertaconazole topical (Ertaczo)?

Serious side effects are not expected to occur with the use of sertaconazole topical. Stop using sertaconazole topical and contact your doctor if you experience unusual or severe itching, redness, burning, blistering, swelling, oozing, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at...

DOSAGE AND ADMINISTRATION

In the treatment of
interdigital tinea pedis, ERTACZO cream, 2%, should be applied twice daily for
4 weeks. Sufficient amount of ERTACZO cream, 2%, should be applied to cover
both the affected areas between the toes and the immediately surrounding
healthy skin of patients with interdigital tinea pedis.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug, and may not reflect the rates observed in practice.

In a dermal sensitization trial, 8 of 202 evaluable
subjects tested with ERTACZO® cream, 2%, and 4 of 202 evaluable
subjects tested with vehicle, exhibited a slight erythematous reaction in the
challenge phase. There was no evidence of cumulative irritation or contact
sensitization in a repeated insult patch test involving 202 healthy volunteers.

Postmarketing Experience

The following adverse reactions have been identified
during post-approval use of ERTACZO cream, 2%. Because these reactions are
reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.

In post-marketing surveillance for ERTACZO cream, 2%, the
following were reported:

Patient Counseling Information

Use ERTACZO cream, 2%, as directed by the physician. The
hands should be washed after applying the medication to the affected area(s).
Avoid contact with the eyes, mouth, vagina and other mucous membranes. ERTACZO
cream, 2%, is for external use only.

Dry the affected area(s) thoroughly before application,
if you wish to use ERTACZO cream, 2%, after bathing.

Use the medication for the full treatment time
recommended by the physician, even though symptoms may have improved.

Inform the physician if the area of application shows
signs of increased irritation, redness, itching, burning, blistering, swelling
or oozing.

Avoid the use of occlusive dressings unless otherwise
directed by the physician.

Do not use this medication for any disorder other than
that for which it was prescribed.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

In a rat dermal carcinogenicity study, topical
administration of sertaconazole nitrate cream for up to 102 weeks did not
increase the number of neoplastic lesions compared to control animals, at
sertaconazole nitrate doses of up to 800 mg/kg/day (approximately 200 times the
maximum recommended human dose based on a body surface area comparison).

No clastogenic potential was observed in a mouse
micronucleus test. Sertaconazole nitrate was considered nonclastogenic in the
in vivo mouse sister chromatid exchange assay. There was no evidence that
sertaconazole nitrate induced unscheduled DNA synthesis in primary rat
hepatocyte cultures.

At oral doses up to 60 mg/kg/day (16 times the maximum
recommended human dose based on a body surface area comparison), sertaconazole
nitrate exhibited no toxicity or adverse effects on reproductive performance or
fertility in male or female rats.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies
conducted with ERTACZO cream in pregnant women. ERTACZO cream should be used
during pregnancy only if the potential benefit justifies the potential risk to
the fetus.

Reproduction studies have not been performed with ERTACZO
cream. Sertaconazole nitrate did not produce any evidence of maternal toxicity,
embryotoxicity or teratogenicity in rats and rabbits at an oral dose of 160
mg/kg/day (40 times (rats) and 80 times (rabbits) the maximum recommended human
dose based on a body surface area comparison). A reduction in live birth
indices and an increase in the number of still-born pups were seen at doses of
80 and 160 mg/kg/day sertaconazole nitrate in an oral peri-and post-natal
development study in rats.

Nursing Mothers

It is not known if sertaconazole is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when prescribing ERTACZO cream, 2%, to a nursing woman.

Pediatric Use

The efficacy and safety of ERTACZO cream, 2%, have not
been established in pediatric patients below the age of 12 years.

Geriatric Use

Clinical trials of ERTACZO cream, 2%, did not include
sufficient numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects.

CLINICAL PHARMACOLOGY

Mechanism Of Action

Pharmacokinetics

In a multiple dose
pharmacokinetic trial that included 5 male subjects with interdigital tinea
pedis (range of diseased area, 42 -140 cm²; mean, 93 cm²),
ERTACZO cream, 2%, was topically applied every 12 hours for a total of 13 doses
to the diseased skin (0.5 grams sertaconazole nitrate per 100 cm²).
Sertaconazole concentrations in plasma measured by serial blood sampling for 72
hours after the thirteenth dose were below the limit of quantitation (2.5
ng/mL) of the analytical method used.

Microbiology

Mechanism of Action

Sertaconazole, an azole
antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol
demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol.
Ergosterol is a key component of fungal cell membranes and lack of this
component leads to fungal cell injury by leakage of key constituents in the
cytoplasm from the cell.

Activity In Vitro and in
Clinical Infections

Sertaconazole nitrate has been
shown to be active against isolates of the following microorganisms in clinical
infections [see INDICATIONS AND USAGE]:

Clinical Studies

In two randomized, double-blind, clinical trials,
subjects 12 years and older with interdigital tinea pedis applied either
ERTACZO cream, 2%, or vehicle, twice daily for four weeks. Subjects with
moccasin-type (plantar) tinea pedis and/or onychomycosis were excluded from the
trial. Two weeks after completion of therapy (six weeks after beginning
therapy), subjects were evaluated for signs and symptoms related to
interdigital tinea pedis.

In clinical trials, complete
cure in sertaconazole treated subjects was achieved in 32 of 160 (20%) subjects
with Trichophyton rubrum, in 7 of 28 (25%) subjects with Trichophyton
mentagrophytes and in 1 of 13 (15%) subjects with Epidermophyton floccosum.

PATIENT INFORMATION

ERTACZO
(er-tack-zo)
(sertaconazole nitrate) Cream, 2%

Important information:
ERTACZO cream is for use on skin only. Do not use ERTACZO cream in your eyes, mouth or vagina.

What is ERTACZO cream?

ERTACZO cream is a prescription
medicine used on the skin (topical) to treat athlete's foot that is between the
toes (interdigital tinea pedis) in people 12 years of age and older with normal
immune systems.

It is not known if ERTACZO
cream is safe and effective in children under 12 years of age.

What should I tell my
healthcare provider before using ERTACZO cream?

Before using ERTACZO cream,
tell your healthcare provider about all of your medical conditions, including
if you:

have any allergies

are pregnant or plan to become
pregnant. It is not known if ERTACZO cream will harm your unborn baby.

are breastfeeding or plan to
breastfeed. It is not known if ERTACZO cream passes into your breast milk.

Tell your healthcare
provider about all of the medicines you take, including prescription and
overthe-counter medicines, vitamins, and herbal supplements.

How should I use ERTACZO
cream?

Use ERTACZO cream exactly as
your healthcare provider tells you to use it.

Use ERTACZO cream for the full
treatment time, even if your symptoms improve.

If you take a bath or shower,
dry the affected skin areas well before you apply ERTACZO cream.

Apply ERTACZO cream 2 times a
day for 4 weeks to the affected skin areas between your toes and to the healthy
skin around the affected areas.

Wash your hands after you apply
ERTACZO cream.

Do not cover the treated skin
areas with bandages unless your healthcare provider tells you to.

What are the possible side
effects of ERTACZO cream?

The most common side effects
of ERTACZO cream include: redness, itching, dry skin, burning, blistering, swelling,
drainage and skin tenderness at the treated skin areas. Tell your healthcare
provider if you have any of these skin reactions.

These are not all the possible
side effects of ERTACZO cream. Call your doctor for medical advice about side
effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ERTACZO
cream?

Store ERTACZO cream at room
temperature between 68°F to 77°F (20°C to 25°C).

Keep ERTACZO cream and all
medicines out of the reach of children.

General information about
the safe and effective use of ERTACZO cream

Medicines are sometimes
prescribed for purposes other than those listed in a Patient Information
leaflet. You can ask your healthcare provider or pharmacist for information
about ERTACZO cream that is written for health professionals. Do not use
ERTACZO cream for a condition for which it was not prescribed. Do not give
ERTACZO cream to other people, even if they have the same symptoms you have. It
may harm them.